Sodium Chloride Irrigation
» Sodium Chloride Irrigation is Sodium Chloride Injection that has been suitably packaged, and it contains no antimicrobial agents. It contains not less than 95.0 percent and not more than 105.0 percent of the labeled amount of NaCl.
Packaging and storage— Preserve in single-dose glass or plastic containers. Glass containers are preferably of Type I or Type II glass. The container may be designed to empty rapidly and may contain a volume of more than 1 L.
Labeling— The designation “not for injection” appears prominently on the label.
Identification— It responds to the tests for Sodium 191 and for Chloride 191.
Bacterial endotoxins 85 It contains not more than 0.5 USP Endotoxin Unit per mL.
Sterility 71: meets the requirements.
Other requirements— It meets the requirements for pH, Iron, Heavy metals, and Assay under Sodium Chloride Injection.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Daniel K. Bempong, Ph.D.
Senior Scientist
1-301-816-8143
(MDPS05) Monograph Development-Pulmonary and Steroids
Reference Standards Lili Wang, Technical Services Scientist
1-301-816-8129
RSTech@usp.org
85 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
1-301-816-8339
(MSA05) Microbiology and Sterility Assurance
71 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
1-301-816-8339
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 3571